Daiichi Sankyo and Merck Withdraw BLA for Ifinatamab Deruxtecan

The Biologics License Application (BLA) for ifinatamab deruxtecan, a treatment for patients with previously treated extensive-stage small cell lung cancer, has been voluntarily withdrawn by Daiichi Sankyo and Merck. The decision was made after discussions with the U.S. Food and Drug Administration (FDA), which determined that data from the IDeate-Lung01 phase 2 trial did not meet the requirements for accelerated approval.

The FDA's accelerated approval pathway allows for earlier approval of medicines based on surrogate endpoints to treat serious conditions where there is an unmet medical need. The companies stated that they are continuing to evaluate the role of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer and other types of difficult-to-treat cancer.

The IDeate-Lung02 phase 3 trial, which is evaluating the efficacy and safety of ifinatamab deruxtecan versus treatment of physician’s choice of chemotherapy in patients with relapsed ES-SCLC following disease progression with only one prior line of platinum-based chemotherapy, continues to enroll patients.